Irrigating intraluminal suction inner cannula system

ABSTRACT

An irrigating intraluminal suction inner cannula system for a tracheostomy tube may be a suction-powered system that may be used for suction alone or a combination of rinse and intraluminal suction for tracheostomy tubes in place of conventional catheter-based intraluminal suction. An inner cannula includes chambers, or regions, and holes that facilitate intraluminal suction and cleaning at multiple locations within the tracheostomy tube. It may be applied/actuated by a patient, healthcare worker, caretaker, or via an electronic system either on-demand or on regular or triggered intervals, in either inpatient/hospital or outpatient/ambulatory care setting.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Ser. No. 17/643,816 filed Dec.10, 2021, and Provisional Patent Application Ser. No. 63/124,599 filedDec. 11, 2020, which are hereby incorporated by reference in theirentirety.

BACKGROUND

Intubation refers to the placement of an endotracheal breathing tubeinto a patient's airway, terminating in the trachea. The breathing tubemay be inserted orally, nasally, or via tracheostomy—an insertion routethrough the skin and soft tissues of the neck—through and ultimatelyterminating within the trachea. These measures are taken to eithertemporarily or permanently support breathing or ventilation. Risks andproblems associated with placement, use, and care of an endotrachealbreathing tube range from discomfort and inconvenience to seriousmedical risks and poor health outcomes.

Tracheostomy tube care requires regular evacuation of secretions fromwithin the innermost lumen of the tube (i.e., “intraluminal”) for safeuse and comfort. In some situations, evacuation may need to be performedas frequently as every 30 minutes. Even when not sedated, few patientsare able to perform effective, safe, regular catheter-based intraluminalsuctioning without assistance, thus rendering them dependent upon othersto perform this vital task, often leading to depression, anxiety, andagitation. Even with assistance, patients frequently experiencediscomfort during suctioning procedures. The reasons for this aretwo-fold: first, frequent misuse of suction catheter (i.e., suctioncatheter is applied too deep/proximal within the airway); and second,patient's inability to time application of suction (negative pressure)during their breath cycle, leading to “surprise” suctioning and itsresultant breathlessness sensation, change in airway pressures, andelicitation of cough reflex.

FIGS. 7A-7C illustrate various aspects of relevant basic anatomy ofendotracheal tubes, and prior art tracheostomy tube features. FIG. 7A isa cross-sectional side view diagram of patient 700 showing various typesof endotracheal tubes. FIG. 7B is a perspective view of a tracheostomytube with an inner cannula, and FIG. 7C is a perspective view of afenestrated tracheostomy tube and inner cannula. FIGS. 7A-7C are bestviewed together in the following discussion.

A patient 700 has a trachea 702 that is part of the airway to the lungs(not shown) of patient 700. To support breathing, patient 700 may beintubated in several ways that are illustrated in FIG. 7A. Intubationmay be achieved by a longer nasotracheal tube via path 704 insertedthrough the nasal passages, past vocal cords 710, and into trachea 702.Alternatively, a similar length oral endotracheal tube via path 706 maybe inserted through the oral cavity and into trachea 702. Further, ashorter tracheostomy tube 708 may be inserted directly into trachea 702through a surgical tracheostomy, region 712.

During positive pressure or mechanical ventilation, an inflatable cuff714 surrounding tracheostomy tube 708 may be inflated via cuff inflationvalve 716, external monitoring balloon 718, and associated tubing 720 toprovide a seal between tracheostomy tube 708 and trachea 702 to preventair leak around the tube. This is referred to as a “cuffed” tube. Cuff714 may be either inflated or deflated, depending on the needs ofpatient 700. A comparable tube without such a cuff is referred to as an“uncuffed” tube as shown, for example, in FIG. 7C.

As shown in FIG. 7B, tracheostomy tube 708 includes a flange 722 whichis placed against the neck of patient 700 to maintain tracheostomy tube708 in the correct position and provide certain functionality. Aremovable inner cannula 724 is an additional feature of some prior arttracheostomy tubes, and may be incorporated with either cuffed oruncuffed tracheostomy tubes. Air is exchanged with patient 700 throughhub 726 via the innermost lumen of tracheostomy tube 708 (or inneraspect, or lumen, of the inner cannula 724, if present). Hub 726 ofinner cannula 724 includes clips 728 that engage with clip attachments730 on flange 722.

FIG. 7C illustrates principles of a fenestrated tracheostomy tube. Afenestration 732 is included in tracheostomy tube 708 above a region 734where an inflatable cuff would be located. A corresponding fenestration736 may be included in inner cannula 724, if used. Fenestrations 732 and736 permit airflow, which allows patient 700 to speak and cough moreeffectively. The methodologies, concepts, and designs, herein applied toand described using tracheostomy tubes, may also be applied tonasotracheal tubes and oral endotracheal tubes.

Most prior art secretion management processes use only suction to clearsecretions from a tracheostomy tube. At present, there is no manner tosafely rinse the inner lumen of a tracheostomy tube to prevent build-upof secretions, clogging, and acute loss of airway. As a result, thepatient may be subjected to more advanced intervention or additionalprocedures due to inadequate clearing of the tracheostomy tube.

Prior art intraluminal tracheostomy secretion clearance through manualsuction-based catheters may also introduce risk of infection to thepatient and frequently causes airway trauma. It can also causesignificant patient and caretaker psychosocial distress, displacedpatient autonomy, taxed healthcare personnel resources, and burdenedcaretakers, all of whom may be exposed to airborne pathogens from thepatient's airway. Such secretion clearance also needs to be performedfrequently, thus further taxing healthcare personnel and/or caretakertime and resources as well as making the patient passive in their owncare.

Presently available tracheostomy tubes that incorporate irrigationand/or suction functions do so at a single site within the airway (i.e.,subglottic/“above the cuff”, or proximal tip) and most commonly, notwithin the lumen of the tube. Those that evacuate the lumen of the tubedo not address the distal tip or the extraluminal sections, andfurthermore, do so without irrigation, thus making them prone toimminent airway loss from clogging. None of these devices have gainedwidespread acceptance in clinical use, and thus, clogging/airway loss,infection, and the burdens of standard, manual, catheter-basedintraluminal suction systems remain the mainstay of tracheostomy tubecare. Additionally, failure or clogging of these designs typicallyrequires removal of the entire tracheostomy tube to cure, which can bedangerous.

SUMMARY

An irrigating intraluminal suction inner cannula system for atracheostomy tube may be a suction-powered system that may be used forsuction alone or a combination of rinse and intraluminal suction fortracheostomy tubes in place of conventional catheter-based intraluminalsuction. An inner cannula includes chambers, or regions, and holes thatfacilitate intraluminal suction and cleaning at multiple locationswithin the tracheostomy tube. It may be applied/actuated by a patient,healthcare worker, caretaker, or via an electronic system eitheron-demand or on regular or triggered intervals, in eitherinpatient/hospital or outpatient/ambulatory care setting.

In a first aspect, an inner cannula for use with a tracheostomy tubeincludes a first tube having a first diameter for insertion in thetracheostomy tube, said first tube further comprising a plurality ofholes between an intraluminal space of the first tube and an outersurface of the first tube, and one or more ridges on the outer surfaceof the first tube that divide an airspace surrounding the outer surfaceinto a plurality of regions; and a second tube fused to a distal end ofthe first tube and having a second diameter larger than the firstdiameter, the second tube comprising a first passage between an outersurface of the second tube and a first region of the plurality ofregions and a second passage between an outer surface of the second tubeand a second region of the plurality of regions.

In a second aspect, an irrigating intraluminal suction inner cannulasystem includes an outer tracheostomy tube and an inner cannulapositioned inside the outer tracheostomy tube. The inner cannulaincludes a first tube having a first diameter for insertion in the outertracheostomy tube, said first tube further comprising a plurality ofholes between an intraluminal space of the first tube and an outersurface of the first tube, and one or more ridges on the outer surfacethat divide an airspace between the outer surface of the inner cannulaand an inner surface of the outer tracheostomy tube into a plurality ofregions; and a second tube fused to a distal end of the first tube andhaving a second diameter larger than the first diameter, the second tubecomprising a first passage between an outer surface of the second tubeand a first region of the plurality of regions and a second passagebetween the outer surface of the second tube and a second region of theplurality of regions. The system also includes an irrigant line attachedto the first passage in the second tube and in communication with thefirst region a suction line attached to the second passage in the secondtube and in communication with the second region; and an actuatingdevice coupled between the irrigant line and a source of irrigant andcoupled between the suction line and a vacuum source, said actuatingdevice controllably connecting the irrigant line to the source ofirrigant and the suction line to the vacuum source.

In a third aspect, an irrigating intraluminal suction and extraluminalsuction inner cannula system includes an outer tracheostomy tubecomprising one or more openings along its length and an inner cannulapositioned inside the outer tracheostomy tube, the inner cannulaincludes a first tube having a length and diameter for insertion in theouter tracheostomy tube, said first tube further comprising a pluralityof openings between an intraluminal space of the first tube and an outersurface of the first tube, a first ridge dividing the outer surface ofthe first tube into an irrigation region and a first suction region, anda second ridge creating a second suction region on the outer surface ofthe first tube; and a second tube fused to a distal end of the firsttube and having a diameter larger than the first tube. The system alsoincluding an irrigant line attached to an irrigant passage in the secondtube and in communication with an airspace formed between the outersurface of the first tube and an inner surface of the outer tracheostomytube in the irrigation region; a first suction line attached to a firstsuction passage in the second tube and in communication with an airspaceformed between the outer surface of the first tube and an inner surfaceof the outer tracheostomy tube in the first suction region; a secondsuction line attached to a second suction passage in the second tube andin communication with an airspace formed between the outer surface ofthe first tube an inner surface of the outer tracheostomy tube in thesecond suction region; and an actuating device coupled between theirrigant line and a source of irrigant and coupled between the first andsecond suction lines and a vacuum source, said actuating devicecontrollably connecting the irrigant line to the source of irrigant andthe first and second suction lines to the vacuum source.

In another aspect, a method of cleansing a tracheostomy tube having anouter tracheostomy tube and an inner cannula comprising a plurality ofholes and one or more ridges dividing an airspace between the outertracheostomy tube and the inner cannula into a plurality of regions whenthe inner cannula is inserted in the outer tracheostomy tube, includesattaching a suction line to the inner cannula so that it is incommunication with a first region of the plurality of regions; attachingan actuating device between the suction line and a vacuum source, saidactuating device controllably connecting the suction line to the vacuumsource; and controlling the actuating device to suction from a lumen ofthe inner canula through a first portion of the plurality of holes, thefirst region and the suction line.

Further, the method may include attaching an irrigant line to the innercannula so that it is in communication with a second region of theplurality of regions; attaching the actuating device between theirrigant line and a source of irrigant, said actuating devicecontrollably connecting the irrigant line to the source of irrigant; andcontrolling the actuating device to provide irrigant to the lumen of theinner canula through a second portion of the plurality of holes, thesecond region and the irrigant line.

Use of the irrigating intraluminal suction inner cannula system does notpreclude the use of present standard catheter-based intraluminalsuctioning, if needed or desired. The use of the irrigating intraluminalsuction inner cannula system also does not limit the use of existingsubglottic extraluminal (e.g., subglottic) suctioning systems, and mayalso incorporate these designs.

In the event of suboptimal performance of the irrigating intraluminalsuction inner cannula system, the inner cannula may be removed andreplaced without removing the tracheostomy tube. Lastly, in certainsituations (e.g., when attached to mechanical ventilation, or when usinga filter or other such cap externally to limit secretions) theirrigating intraluminal suction inner cannula system achieves bothirrigation and suction within a “closed system,” thus reducing oreliminating potentially infectious aerosols and/or particulates thatresult from existing “open” type catheter-based tracheostomy suctioning,and thereby reducing the risk to health care workers and caretakers torespiratory-borne pathogens.

Embodiments of the irrigating intraluminal suction inner cannula systemdisclosed herein address these concerns via its novel design and use ina closed system, as described hereinbelow. For example, by creatingseparate chambers for suction and irrigation within the tracheostomytube—the irrigating intraluminal suction inner cannula system achievesintraluminal tracheostomy suction and irrigation in a way that ispresently unavailable. As a result, the shortcomings and risks of priorart technology are avoided.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of an irrigating intraluminal suction innercannula, in embodiments.

FIG. 1B is an oblique view of the cannula of FIG. 1A.

FIG. 1C is a top view of the cannula of FIG. 1A.

FIG. 1D is a bottom view of the cannula of FIG. 1A.

FIG. 1E is a cross-sectional view of the inner cannula of FIG. 1A.

FIG. 2A is a cutaway side view of an irrigating intraluminal suctioncannula with an outer lumen, in embodiments.

FIG. 2B is an oblique view of the cannula system of FIG. 2A.

FIG. 2C is an expanded view of a portion of the cannula system of FIG.2A.

FIG. 3 is a side view of a cannula with irrigant and suctionconnections, in embodiments.

FIG. 4 is an irrigating intraluminal suction inner cannula system, inembodiments.

FIG. 5 is a flowchart illustrating a method of using an irrigatingintraluminal suction inner cannula system.

FIG. 6A is an oblique view of the irrigating intraluminal suction innercannula system incorporating additional extraluminal subglottic suctioncapabilities and an accompanying cuffed outer tracheostomy tube, inembodiments.

FIG. 6B is an oblique view of an alternate irrigating intraluminalsuction inner cannula system incorporating additional extraluminalsubglottic suction capabilities and accompanying cuffed outertracheostomy tube, in embodiments.

FIG. 6C is an oblique view of an irrigating intraluminal suction innercannula system incorporating both irrigation and suction of theextraluminal subglottic region, with accompanying specifically designedcuffed outer tracheostomy tube, in embodiments.

FIGS. 6D-6E are oblique views of an irrigating intraluminal suctioninner cannula system for use with a fenestrated outer tracheotomy tube,in embodiments.

FIG. 7A is a cross-sectional side view diagram of a patient showingvarious types of prior art endotracheal tubes, in embodiments.

FIG. 7B is a perspective view of a prior art tracheostomy tube with aninner cannula, in embodiments.

FIG. 7C is a perspective view of a prior art fenestrated tracheostomytube and inner cannula, in embodiments.

DETAILED DESCRIPTION

The principles according to the present disclosure may have particularapplication in a tracheostomy tube, and thus will be described belowchiefly in this context. It is also understood, however, that principlesand aspects according to the present disclosure may be applicable tooral endotracheal or nasotracheal tubes, or other irrigating suctioncatheters used in healthcare or industry.

In the discussion above and to follow, the term “proximal” is used toindicate closer toward the lung of a patient and/or toward the lung-sidetip of a tracheostomy tube. The term “distal” is used to indicatefarther away from a patient and/or toward the equipment outside thepatient or the external end of the tracheostomy tube. Other terms usedherein may be defined as follows:

-   -   Cannula—A tube that is inserted into a body cavity, duct, or        vessel.    -   Lumen—The space inside a cannula.    -   Intraluminal—Within the innermost lumen, between the ends of the        cannula.    -   Extraluminal—Outside the cannula or at either or both ends of        the cannula. As used herein, extraluminal applies to the outer        most tube in any context, or at either end of a tube or cannula.    -   Subglottic—Generally, situated below the glottis. As used        herein, subglottic indicates an extraluminal region of a trachea        that is above an inflatable cuff of a tracheal tube and below        the vocal cords.

The innermost airway lumen of an endotracheal tube, includingtracheostomy tubes, ranges in inner diameter from 2 mm in neonataltubes, and up to approximately 14 mm inner diameter in adults, with thelower range being limited by effective airflow/ventilation to and fromthe patient's airway. The upper range of size is impacted by the outerdiameter of an endotracheal tube or tracheostomy tube, and its abilityto fit in the airway—specifically, beyond the vocal cords/glottis andinto the trachea—generally limited in size to no larger thanapproximately 15 mm.

An irrigating intraluminal suction inner cannula system as discussedherein generally includes a tracheostomy tube and inner cannula. Theinner cannula is inserted within the tracheostomy tube and provides bothsuction and irrigation of the tracheostomy tube. FIGS. 1A-1D depictinner cannula 100, in an embodiment, while FIGS. 2A-2C depict innercannula 100 in combination with a tracheostomy tube to form anirrigating intraluminal suction inner cannula system 200, inembodiments.

FIG. 1A shows a side view of inner cannula 100 with intraluminal suctionand irrigation, in embodiments. FIGS. 1B, 1C and 1D show oblique, top,and bottom views of inner cannula 100, respectively. FIG. 1E is across-sectional view of FIG. 1A at line 1E-1E. FIGS. 1A-1E are bestviewed together in the following description.

Inner cannula 100 includes a single curved semi-rigid plastic first tube102 fused to rigid plastic second tube 104. Inner cannula 100 may fitinto a patient's existing tracheostomy tube 202 (as shown in FIGS.2A-2D) or into a tracheostomy tube specifically designed for use withinner cannula 100. The outer tracheostomy tube 202 may or may not beequipped with a balloon cuff (such as cuff 604 of FIG. 6 ) for use withpositive pressure ventilation (i.e., “cuffed” or “uncuffed” tracheostomytubes) known in prior art. Inner cannula 100 may be secured withappropriate retaining clips 106 for patient's native tracheostomy tube202 or accompanying specifically designed tracheostomy tube. Innercannula 100 may have a variety of diameters, thicknesses and lengthsdepending on the needs of the patient or its use in an endotrachealtube, for example. In embodiments, semi-rigid plastic first tube 102 hasa smaller diameter than rigid plastic second tube 104. Intraluminalspace 132 is formed throughout the interior of inner cannula 100.

Inner cannula 100 includes a continuous elevated ridge 112 on an outersurface of first tube 102, in a specific arrangement and height as toabut the inner lumen of a rigid outer tracheostomy tube 202. Ridge 112divides the outer surface of first tube 102 into several regions 124,126, or chambers. Starting from point 114 where first tube 102 is fusedto second tube 104, ridge 112 extends along the length of first tube 102in the proximal direction, around the circumference of first tube 102 atpoint 116, then back along first tube 102 in the distal direction.Before reaching second tube 104, ridge 112 again goes around thecircumference of first tube 102 at point 118, extends in the proximaldirection to point 120 then back up first tube 102 to culminate at point122 where first tube 102 is fused to second tube 104.

The regions 124, 126 of first tube 102 formed by ridge 112 each containa series of openings between the outer surface and intraluminal space132 to allow for the movement of air and/or fluid. Region 124 includesholes 125 and is located on either side of first tube 102 while region126 includes slots 127 and is located on the top and bottom of firsttube 102. Although holes and slots are shown, this is for purposes ofillustration. In embodiments, the locations of holes and slots may bereversed. In addition, all of the openings may be slots, or all may beholes, or holes 125 and 127 may be of varying sizes or other shapes tofacilitate function. Similarly, the shapes and orientations of theridges are shown in FIGS. 1A-1E for purposes of illustration only andmay be configured differently to facilitate the functions describedherein.

In embodiments, the rigid plastic second tube 104 includes first passage128 and second passage 130 positioned 90 degrees from retaining clips106, although other locations are contemplated as long as first andsecond passages 128 and 130 connect to regions 124 and 126,respectively. First and second passages 128 and 130 may be slots orenclosed passages through second tube 104. First passage 128 extends atan angle from an upper external surface of second tube 104 to an openingin the proximal end of second tube 104 adjacent to first tube 102. Inembodiments, first passage 128 communicates with the airspace created byridge 112 between first tube 102 and an abutting inner surface of anouter tracheostomy tube 202 in region 124. Holes 125 communicate betweenthe airspace of region 124 and intraluminal space 132. In a similar way,second passage 130 extends at an angle from a lower external surface ofsecond tube 104 opposite of first passage 128 to an opening in theproximal end of second tube 104 adjacent to first tube 102 but oppositefrom the opening of first passage 128. In embodiments, second passage130 also communicates with an airspace created between ridge 112 betweenfirst tube 102 and an abutting inner surface of an outer tracheostomytube 202 but in region 126 instead of region 124. Region 126 includesslots 127, which also communicate between the airspace of region 126 andintraluminal space 132.

As discussed in more detail in connection with FIG. 3 , flexible plastictubing having a varying diameter, thickness, and length may be connectedto first passage 128 on the upper surface of second tube 104. As furtherdiscussed below, flexible plastic tubing having a varying diameter,thickness, and length may be connected to second passage 130 on thelower surface of second tube 104. References to upper surface and lowersurface are for purposes of illustration and first and second passages128, 130 may be located at any position around second tube 104.

FIGS. 2A-2C show inner cannula 100 as it would be inserted into an outertracheostomy tube 202, creating irrigating intraluminal suction innercannula system 200. Components of FIGS. 2A-2C not specifically addressedbelow are the same as components described above in connection withFIGS. 1A-1E.

System 200 includes an outer tracheostomy tube 202, which representseither the patient's existing tracheostomy tube or one specificallydesigned for use with inner cannula 100. In embodiments, aspecifically-designed outer tracheostomy tube 202 may fit with innercannula 100 as part of a kit. For example, outer tracheostomy tube 202may have indentations in its inner surface that engage with ridge 112and improve the function of inner cannula 100. As depicted in FIGS. 2A,only a portion of outer tracheostomy tube 202 is shown. A portion ofouter tracheostomy tube 202 is cutaway to show first tube 102 and theengagement between ridge 112 and an internal surface of outertracheostomy tube 202. In addition, outer tracheostomy tube 202 wouldextend towards second tube 104 and provide a mechanism for engagingretaining clips 106. This mechanism could have several different formsand is omitted for clarity of illustration. FIG. 2B shows system 200with a full outer tracheostomy tube 202.

The length of outer tracheostomy tube 202 is approximately equal tofirst tube 102 of inner cannula 100 as shown in FIG. 2B. The diameter ofouter tracheostomy tube 202 is selected such that ridge 112 abuts theinner surface of outer tracheostomy tube 202 as shown at point 134 toform an airspace divided into regions 124 and 126. End 136 of firstpassage 128 in second tube 104 communicates with region 124 while end138 of second passage 130 communicates with region 126 in second tube104. As shown more clearly in FIGS. 1C and 1D, region 126 includes areason opposite sides of first tube 102. In embodiments, ridge 112 may beformed on the inner aspect as part of outer tracheostomy tube 202 whilestill providing the regions or chambers discussed above. Alternatively,ridge 112 may be formed as part of both inner cannula 100 and outertracheostomy tube 202 creating a single inseparable device.

In operation, inner cannula 100 may be used for suctioning and clearanceof secretions in a patient's tracheostomy tube. Secretions build up on aregular basis and often require the use of intraluminal catheter basedsuctioning procedures, typically performed by another individual atpresent and often too viscous to be easily retrieved. Inner cannula 100may fit into an existing tracheostomy tube or specifically designedaccompanying tracheostomy tube. Once secured with retaining clips 106for the patient's native tracheostomy tube (or accompanying tracheostomytube), then either suction alone, or suction along with irrigation canbe applied to remove secretions from the intraluminal space as well asthe adjacent proximal end of the patient's tracheostomy tube. Inembodiments, suction, or suction and irrigation, may also be applied toan extraluminal subglottic region. Irrigation may be performed with anirrigant solution, for example, saline. In embodiments, other solutionsmay be used, such as mucolytics, antibiotics, antifungals, steroids, orother medications. The irrigation combination with suction applicationalso washes the inner lumen of the tracheostomy tube and suction chamberand therefore thins (decreases viscosity) the secretions to allow foreasier suctioning and clearance of these secretions to prevent build-upand blockage, as well as to decrease the burden of pathogenic microbialcolonization of the tube and airway tissues.

In embodiments, a method of using any of the cannulas disclosed hereinis described in connection with FIGS. 3 and 4 , which are best viewedtogether in the following description. For purposes of illustration,inner cannula 100 is depicted without outer tracheostomy tube 202. Innercannula 100 fits into either a) the patient's existing tracheostomy tubeor into b) an accompanying specifically designed tracheostomy tube—botha and b options represented by irrigating intraluminal suction innercannula system 200 as disclosed herein. Once secured with retainingclips 106 for patient's native tracheostomy tube or accompanyingspecifically designed tracheostomy tube, the proximal end of suctionline 302 is received by second passage 130. Suction line 302 may be aflexible plastic tubing terminating in fusion with a standard suctionapplication tip 304. The proximal end of irrigant line 306 is receivedby first passage 128. Irrigant line 306 may be a flexible plastic tubingterminating in fusion with a with standard intravenous (IV) tubingconnection 308, for example, a luer lock. In embodiments, suction line302 and irrigation line 306 have a resting/failsafe closed positionwhich prevent: a) loss of positive pressure (i.e., a leak) in thesetting of mechanical ventilation, b) spontaneous flow of irrigant, andc) spontaneous application of suction to the device.

FIG. 4 shows irrigating intraluminal suction inner cannula system 200connected with additional apparatus to form active use system 400.Active use system 400 is an example of system 200 in use. A distal endof suction line 302 is applied to suction line input 402 on actuatingdevice 404. Suction line 406 distal to actuating device 404 is coupledto input 408 of vacuum source receptacle 410. Receptacle 410 may beconnected to a continuous suction/negative pressure source such as, forexample, a hospital wall-mount vacuum fitting or portable suction unit.

Similarly, irrigant line 306 from inner cannula 100 is coupled to theappropriate irrigant line input 412 on actuating device 404. Irrigantline 414 that is distal to the actuator device 404 is applied toirrigant bottle 416 through cap 418 with a straw to the bottom ofirrigant bottle 416. A vent 420 on cap 418 may be opened for ease of useand facilitation of irrigant flow with less resistance. Irrigant bottle416 must either be placed on the floor near the patient or kept at leastone vertical foot (or other determined distance as to prevent gravityflow when actuating device is open) below the patient's tracheostomytube at all times. In embodiments, irrigant bottle 416 may be, forexample, a vent-option irrigant bottle or a hanging bag attached to apatient bed or independent stand.

Once all components of FIG. 4 are appropriately secured, actuatingdevice 404 is controlled to perform an operation of either suction only,or a combination of suction and irrigation through the actuation ofbuttons 422 and 424. Suction-only actuation using button 424 will drawair and secretions from within the intraluminal space 132 of innercannula 100, through the region 126 formed by ridge 112 between innercannula 100 and the inner surface outer tracheostomy tube 202 (FIGS.2A-2D), and out distally through lines 302 and 406 eventually ending inthe vacuum source receptacle 410, thus clearing intraluminal secretions.Although actuating device 404 is described in connection with buttons,any mechanism for controlling the operation of actuating device 404 andactive use system 400 to provide the functions described herein may beused. Additional buttons and functions may also be provided as part ofactuating device 404 and active use system 400.

If both suction button 424 and irrigation button 422 are actuated at thesame time, irrigant originating distally in irrigant bottle 416 will bedrawn through lines 414 and 306 by negative pressure applied throughsuction lines 302 and 406. Irrigant will be drawn into region 124 formedby ridge 112 between inner cannula 100 and the inner surface of outertracheostomy tube 202. Irrigant will enter the intraluminal space 132 ofinner cannula 100 through holes 125, mix with intraluminal air andsecretions, and then exit through slots 127 (FIGS. 1A-1D) into region126. This flow of irrigant will thin secretions and rinse theintraluminal space 132 of inner cannula 100, and eventually end in thevacuum source receptacle 410.

Actuating device 404 may be designed in a number of ways, as long as itprovides control buttons or other actuators and a connection betweensuction and irrigant lines from a tracheostomy cannula, and sources ofirrigant and suction, respectively. In embodiments, actuating device 404includes buttons 422 and 424, which are able to be moved/depressed intoalignment. More or fewer buttons may be provided. An outer plastichousing of actuating device 404 is shown as including input 402 for hassuction line 302 and an output on the opposite side for line 406 providesuction to inner cannula 100. Outer plastic housing of actuating device404 also has an input 412 for irrigant line 306 and an output forirrigant line 414 on the opposite side which passes through cap 418 intostandard irrigant bottle 416. These inputs and outputs may be providedat any convenient location on actuating device 404. Actuating device 404functions such that only when button 424 is depressed are the lumens ofthe two lines 302 and 406 aligned to allow flow, otherwise preventingflow when the button 424 is not actuated. Likewise, only when button 422is depressed are the lumens of lines 306 and 414 aligned to allow flow.In embodiments, actuating device 404 prevents the flow of irrigantwithout application of suction; however, it will accommodate use ofsuction only. Other actuating device mechanisms for connecting lines 302and 306 with lines 406 and 414, respectively, are contemplated. Further,actuating device may be provided as a component of another medicaldevice.

The patient is protected from irrigant-only flow into the intraluminalspace 132 of inner cannula 100 by both actuating device 404 whichprevents irrigant flow in the absence of suction, and by ensuring thatthe irrigant bottle 416 is kept at least one foot (twelve inches)—orother determined distance as to prevent spontaneous flow. In otherwords, irrigant bottle 416 as well as hanging bag or any apparatus forproviding irrigant must be located below the vertical height of thetracheostomy tube at all times in the absence of any other mechanism tolimit flow of irrigant. Other means of controlling the flow of irrigantare contemplated. For example, possibly via use of a variant ofactuating device 404, irrigant may be actively pushed through the sameflow pattern described previously, but done so by means of a pump, orpressurized irrigant canister, in a continuous or pulsating fashion,rather than simply drawn through solely by the negative pressure createdby vacuum source 411. This pump could be placed either proximal ordistal to the actuating device. In embodiments, the holes 125 in innercannula 100 may include a one-way valve or pressure relief type valve,such as a simple slit or defect in the material in this region whichremains closed at baseline and opens with increases in pressure in theirrigant line proximal to the actuating device.

In embodiments, active use system 400 may include additional safeguardsagainst failure. In the event of failure of irrigation or suction, aflow sensor (not shown) would monitor if excessive or unexpected flow ofirrigant is detected and provide an alarm, or other notification, ormeans of cessation. Excessive flow of irrigant may alternatively beimmediately stopped by removal of the inner cannula. Valves,flow-limiters, and mechanical or electrical flow and pressure sensorsare also contemplated.

In the event of malfunction, or for regular interval care, inner cannula100 may be un-clipped, removed, discarded, and replaced with a newcannula. Conventional catheter-based intraluminal suctioning may beperformed with or without inner cannula 100 in place. It is also notablethat operation can be performed while connected to a ventilator/sourceof positive pressure, or not. Furthermore, operation can be performedwith either a cuffed or uncuffed tube or with a fenestrated ornon-fenestrated tracheostomy tube. Control of actuating device 404 maybe performed by the patient, healthcare provider or caretaker. Inembodiments, actuating device 404 may also be actuated by a mechanismdesigned to hold and apply actuation/depression of buttons 422 and 424by means of an electronically controlled device either on-demand bypatient, healthcare provider, caretaker, or on an automated schedule, orat points where certain monitoring input conditions are met andrecognized by an electronic monitoring system. Irrigant bottle 416 maybe replaced as it is depleted or as part of a set schedule. Furthermore,any component may be removed and replaced as part of a set schedule oras deemed necessary by patient, healthcare worker, caretaker, asindicated by an electronic monitoring system, or established protocol.

A variety of methods may be used to manufacture an irrigatingintraluminal suction inner cannula system, in embodiments. For example,inner cannula 100 or system 200 may be created by mold extrusion or bythermally and/or chemically affixing solid plastic roll material ontothe cannula to give its configuration of raised ridges. Holes 125 andslots 127 on first tube 102 may be created by mold extrusion or viaheat, drilling, cutting, grinding, or otherwise subtracting material.First tube 102 may be thermally and/or chemically fused with rigidplastic second tube 104. Tubes 102 and 104 may also be manufactured asone piece. Irrigant/irrigation line 306 and suction line 302 may bethermally and/or chemically fused in place to the rigid plastic secondtube 104. Additive methods, such as 3D printing, are also contemplated.

FIG. 5 is a flowchart illustrating a method 500 of using an irrigatingintraluminal suction inner cannula system 200. Method 500 includes steps506 and 508. In embodiments, method 500 also includes at least one ofsteps 502 and 504.

In step 502, inner cannula 100 is inserted into an outer tracheostomytube 202 to create irrigating intraluminal suction inner cannula system200. In an example of step 502, inner cannula 100 fits into an existingouter tracheostomy tube 202 or a specifically designed accompanyingtracheostomy tube. Inner cannula 100 is secured with retaining clips 106to patient's native tracheostomy tube 202 or accompanying tracheostomytube.

In step 504, suction and irrigant lines are connected to inner cannula100. In an example of step 504, suction line 302 is attached to secondpassage 130 in second tube 104. In embodiments, irrigant line 306 isattached to first passage 128 in second tube 104. In embodiments, one orboth of suction line 302 and irrigant line 306 may be permanentlyattached, or fused, to second tube 104.

In step 506, suction and irrigant lines are connected to vacuum andirrigant sources through an actuating device. In an example of step 506,suction line 302 is connected through actuating device 404 and suctionline 406 to vacuum source receptacle 410. Irrigant line 306 is connectedthrough actuating device 404 and irrigant line 414 to irrigant bottle416.

In step 508, actuating device 404 is used to perform suction alone, orsuction along with irrigation of inner cannula 100 or system 200. In anexample of step 508, button 424 on actuating device 404 may be pressedto connect suction line 302 with suction line 406 to remove secretionsfrom the intraluminal space 132 of the patient's tracheostomy tube 202.In addition, irrigant button 422 may be pressed to combineirrigant/irrigation with suction to wash the intraluminal space 132 ofthe tracheostomy tube and region 126 by thinning the secretions to allowfor easier suctioning and clearance within a closed system. Actuatingdevice 404 may be controlled by the patient, hospital personal or othercaregiver. In embodiments, actuating device 404 may be incorporatedwithin a ventilator (not shown) and programmed to coordinate with theoperation of the ventilator. Further, actuating device 404 may be usedwith an electronically controlled device to apply actuation/depressionof actuator buttons (or other method). An additional example would becontrol via ocular control device or neural integrated device as used byimmobile patients such as those with neurodegenerative or paralyticconditions (e.g., Amyotrophic Lateral Sclerosis—ALS, trauma, etc). Inany of these embodiments, actuating device may be actuated eitheron-demand by patient, healthcare provider, caretaker, either on anautomated schedule, or at points where certain monitoring inputconditions are met and recognized by an electronic monitoring system. Inembodiments, this would provide additional flexibility, decreasecare-burden and resources, and minimize exposure of others toaerosolized particles.

Accumulation of oral cavity and pharyngeal secretions in the regionabove an inflated cuff of an outer tracheostomy tube can lead to microaspiration of secretions into the lungs and has been associated with thedevelopment of ventilator assisted pneumonia (VAP.) For this reason,several additional embodiments are contemplated to incorporateextraluminal subglottic suction alone, or irrigation and suctioncombined, in this region while still incorporating the intraluminalirrigation and suction described herein. These embodiments aredemonstrated in FIGS. 6A-6C. Additionally, an irrigating intraluminalsuction inner cannula system as described herein may also be used withfenestrated outer tracheostomy tubes and additional embodiments areshown in FIGS. 6D-6E.

FIG. 6A shows that inner cannula 100 as shown in FIGS. 1A-1D may be usedwith an outer tracheostomy tube with cuff 604 that is provided withadditional suction holes 606. Single or multiple suction holes 606 areprovided in cuffed outer tracheostomy tube 602 in the region of thesubglottis, that is, above cuff 604 of a cuffed outer tracheostomy tube602, and below the vocal cords, as shown in FIG. 7 . Suction holes 606may be positioned on the superior surface of cuffed outer tracheostomytube 602 so as to overly corresponding region 126 of inner cannula 100and thus, extend the intraluminal suction to the subglottic space.Additional suction holes 606 (not shown) may be provided on the oppositeside of cuffed outer tracheostomy tube 602 aligning with thecorresponding region 126. However, because the airspace of the lumen ofthe tracheostomy tube used for ventilation is contiguous with thisextraluminal suction corridor created by this design, during positivepressure ventilation, an air leak into the subglottic space may exist,leading to discomfort or otherwise problematic side effects.Additionally, this may create a pathway for subglottic secretions toenter the intraluminal space and lead to aspiration of the secretionsinto the lower airways. Because of these shortcomings, two additionalsubglottic suction and subglottic irrigation and suction combinationembodiments are contemplated and demonstrated in FIGS. 6B and 6C.

In the embodiment of FIG. 6B, inner cannula 608 is a modified version ofinner cannula 100. The following description refers to the accompanyingdrawings in which the same numbers in different drawings represent thesame or similar elements unless otherwise represented. An additionalpassage 610 is created in second tube 104 for the attachment of asubglottic suction line (not shown). Passage 610 is an example of secondpassage 130. Subglottic suction occurs in region 612 created by ridge614 on the inner cannula. Ridge 614 is similar to ridge 112 in that iscreates a region, or chamber, between inner cannula 608 and outertracheostomy tube 616. Ridge 614 starts at second tube 104, extendsalong the length of inner cannula 608 in the proximal direction, aroundthe circumference of inner cannula 608 at point 618, then extends alongthe length of inner cannula 608 in the distal direction back toterminate at second tube 104. Ridge 112 is reconfigured as shown in FIG.6B so that intraluminal suction, or irrigation and suction, may beprovided with inner cannula 608 as described above.

Notably, there are no holes or slots region 612 as there are in region126 and therefore, no communication between region 612 or extraluminalspace outside outer tracheostomy tube 616 and the intraluminal space ofinner cannula 608. Instead, a slot 620 is located in outer tracheostomytube 616 so that it overlies region 612. By separate or similar controlof an actuating device as described in connection with FIG. 4 , whensuction is applied through passage 610, secretions in the extraluminalsubglottic space will be removed by suction. The embodiment of FIG. 6Bonly provides suction to the extraluminal subglottic space. Firstpassage 128 in second tube 104 may be shifted from its position as shownin FIGS. 1A-1D, but still is contiguous with the region 124, andcommunicates with the opposite side of inner cannula 608 irrigationspace via passthrough region 622. Therefore, a new path of suction iscreated, while still suppling suction and irrigation to all of thepreviously described holes in the inner cannula for purposes ofintraluminal irrigation. A small area of superior intraluminal suctionis sacrificed in this design.

The embodiment of FIG. 6C incorporates both irrigation and suction tothe extraluminal subglottic region, while again still achieving bothintraluminal suction and irrigation. In this embodiment, first passage128 in second tube 104 is again shifted to the side, but in the samemanner as FIG. 6B, it remains contiguous with the region 124 via thesame design of ridge 112 as shown in FIG. 6B. In FIG. 6C, ridge 614 isreplaced with two parallel raised ridges including inner ridge 624 andouter ridge 626. Both inner ridge 624 and outer ridge 626 originate fromsecond tube 104 and terminate again at second tube 104 as describedabove for ridge 614. This creates region 628 within inner ridge 624 andregion 630 between inner ridge 624 and outer ridge 626. Like regions 124and 126, regions 628 and 630 create a chamber between inner cannula 632and outer tracheostomy tube 634. There are no holes or slots in eitherof regions 628 or 630 for communication with the intraluminal space ofinner cannula 632. Passage 638 in second tube 104 is connected to asuction line (not shown) and contiguous with region 628 for providingsuction to extraluminal subglottic region through opening 640 in outertracheostomy tube 634. Passage 642 in second tube 104 is connected to anirrigation line (not shown) and contiguous with region 630 for providingirrigation to the extraluminal subglottic region through openings 644and 646 in outer tracheostomy tube 634. As described above in connectionwith FIG. 4 , an actuating device may cause the flow of irrigant fromthe supply/bottle 416 to be drawn through passage 642 to mix withsecretions in the extraluminal subglottic space, then be drawn outthrough passage 638 to terminate in the same or separate suctioncanister or vacuum source receptacle 410. Other similar variations andrelocations of the raised ridges and entry defects on inner cannula 632and second tube 104 for subglottic suction are contemplated. Therefore,a new path of irrigant flow is created, while still suppling suction andirrigation to all of the previously described holes in the inner cannulafor purposes of intraluminal irrigation.

FIG. 6D shows an embodiment of an irrigating intraluminal suction innercannula 648 for use with a fenestrated outer tracheostomy tube 650.Fenestrated outer tracheostomy tube 650 may be desired in certainclinical scenarios to assess breathing and speaking capabilities. Innercannula 648 is compatible with this type of outer tracheostomy tubedesign, or a specifically designed accompanying outer tracheostomy tube.Outer tracheostomy tube 650 may be either cuffed as shown or uncuffed. Araised, solid, block-like platform 652 is created on inner cannula 648in the region of fenestration 654 of outer tracheostomy tube 650.Platform 652 is sized to abut the inner surface of outer tracheostomytube 650. In this manner, the flow of air to and from the patient'sairway to and from the subglottic region is blocked while irrigation andsuction may still be provided using ridge 112 and regions 124 and 126 asdescribed above. This blockage is sometimes desired.

Alternatively, flow of air to and from the patient's airway through thefenestration in an outer tracheostomy tube to and from the subglotticregion is sometimes desired. To address this, an alternate embodimentshown in FIG. 6E is contemplated for use in fenestrated outertracheostomy tubes that allows for this passage of air throughfenestration 654. In FIG. 6E, irrigation intraluminal inner cannula 656includes a roughly circular or ovoid raised ridge 658 in the same areaand shape of overlying fenestration 654 on outer tracheostomy tube 650.In this embodiment, an accompanying opening within ridge 658 to theintraluminal space inside inner cannula 656 is intentional.

None of the embodiments in FIGS. 6A-6E compromise the irrigation orsuction function of the intraluminal space described previously herein.

Active use system 400 decreases aerosolized airway particles because itis a closed system when used with a ventilator or a tracheostomy tubefilter or nearly closed system when used without one. Either way thisreduces respiratory aerosols and particles as well as the infection riskto others, an inherent risk of standard tracheostomy care.

In the event of malfunction, or for regular interval care, inner cannula100 may be un-clipped, removed, discarded, and replaced with a newcannula without need for replacement of the outer tracheostomy tube.Conventional catheter-based intraluminal suctioning may be performedwith or without inner cannula 100 in place.

A number of changes may be made to inner cannula 100 or system 200. Forexample, additional ridges may be used on first tube 102 to createfurther regions, or chambers/conduits for monitoring equipment and/ormedication delivery. Ridge 112 on first tube 102 may be reconfigured fordifferent patterns and subsequently different shapes of the irrigationand vacuum chambers, which may change their function. Similarly,passages in second tube 104 may be reconfigured for different patternsor shapes to permit functions of irrigation in suction chambers. Ridges112 may allow for communication between the patient's airway to theexternal environment for the purpose(s) of airway monitoring devicesand/or measurements or to deliver medications (droplet, aerosol, etc.).

Outer tracheostomy tube 202 may be configured with grooves or reliefs tohelp facilitate ease of insertion, different or improved function, orcleaning. The holes and/or slot locations, sizes, patterns, and shapeson first tube 102 may be reconfigured for varying flow of liquids andsuction performance. In embodiments, inner cannula 100 may be lengthened(beyond tip of the outer tracheostomy tube 202), or shortened (to withinthe lumen of 202) to further enhance operational capabilities.

The lines for irrigation and suction may be altered to achieve the samesuction by means of different locations on the hard plastic lumen of theinvention, diameters, lengths, and connections. The shape andconfigurations of retaining clips, lumen and ridge sizes, lengths, andexisting fenestrations could be applied to work with different existingtracheostomy tubes presently available, which vary in some or all ofthese regards.

An irrigating intraluminal suction inner cannula system may be used inother applications or areas of technology that requires the frequentreplacement of inner lumens of a tube as a result of build-up of debris,secretions, or other matter; or, a similar system that does not have areplaceable inner lumen/cannula but could benefit from such to preventclogging which results in damage or failure of the system as maypresently be managed by intraluminal catheter-based suction. This couldbe in either medical or non-medical settings.

In healthcare environments, an irrigating intraluminal suction innercannula system may be applied to other medical device/implant tubeswhich communicate with the external environment—such as oralendotracheal tubes, nasotracheal tubes, gastrostomy, colostomy, ornephrostomy tubes, intraperitoneal lumens, surgical drains, or othersuch applications in healthcare. The irrigating intraluminal suctioninner cannula system could be used in many different settings, includingboth inpatient and ambulatory/portable settings.

This function of an irrigating intraluminal suction inner cannula systemmay be directed to or performed by a computer, machine, or otherelectronic means of monitoring and/or actuation of described functions.

An irrigating intraluminal suction inner cannula system, and thedescribed, implied, or resultant use can produce compositions that maybe of use or value. Monitoring of the secretions produced by its use maybe of diagnostic use to healthcare providers. It may also provide fortesting secretions for the presence of certain pathogens which can bedetected or cultured, without introduction of additional instrumentationwithin the patient's airway, thus reducing risks from additionalprocedures.

The health outcomes data obtained by any regularly implemented orautomated use of an irrigating intraluminal suction inner cannulasystem, with or without a machine or electronic control, may be a usefulitem in the creation of patient care protocols, reduction of patientmorbidity and/or mortality, and development of patient care algorithms.Patient health outcomes may be improved as result of improved airwayhygiene, which is a recognized standard of care in patients withtracheostomy tubes.

Functionality of the irrigating intraluminal suction inner cannulasystem requires only that it be appropriately secured and connected to asource of irrigant or other irrigation liquid, and a source of negativepressure (vacuum.) Safe and comfortable function may be enhanced byactuated control of irrigant and suction.

Changes may be made in the above methods and systems without departingfrom the scope hereof. It should thus be noted that the matter containedin the above description or shown in the accompanying drawings should beinterpreted as illustrative and not in a limiting sense. Herein, andunless otherwise indicated: (a) the adjective “exemplary” means servingas an example, instance, or illustration, and (b) the phrase “inembodiments” is equivalent to the phrase “in certain embodiments,” anddoes not refer to all embodiments. The following claims are intended tocover all generic and specific features described herein, as well as allstatements of the scope of the present method and system, which, as amatter of language, might be said to fall therebetween.

Those skilled in the art could rearrange locations or sizes offenestrations/configurations/ridges/volumes/shapes of the describedirrigant and suction chambers, as alternate configurations arecontemplated for various intended functions still within the scope ofprinciples discussed herein.

What is claimed is:
 1. An inner cannula for use with a tracheostomytube, comprising: a tube having a diameter for insertion in thetracheostomy tube, a distal end and a proximal end, said tube furthercomprising: a first continuous ridge on an outer surface of the tube,the first continuous ridge having a height that abuts an inner lumen ofthe tracheostomy tube, wherein the first continuous ridge extends atleast along a first length of the tube in a proximal direction, around acircumference of the tube, and along a second length of the tube in thedistal direction; and a second continuous ridge having a height thatabuts an inner lumen of the tracheostomy tube, wherein the secondcontinuous ridge extends along the first length of the tube in aproximal direction, around a circumference of the tube, and along thesecond length of the tube in the distal direction; wherein the firstcontinuous ridge and the second continuous ridge divide an airspacesurrounding the outer surface into a plurality of separate regionsincluding at least a first region, a second region, and a third region,wherein the third region is in a subglottic region; and a plurality ofholes between an intraluminal space of the tube and an outer surface ofthe tube in the first and second regions.
 2. The inner cannula of claim1, wherein the first region is connectable to a line coupled to a sourceof irrigant.
 3. The inner cannula of claim 1, wherein the second regionand third regions are connected to a line coupled to a vacuum source. 4.The inner cannula of claim 1, further comprising: a third continuousridge on the outer surface of the tube parallel to and within the secondcontinuous ridge, the third continuous ridge having a height that abutsan inner lumen of the tracheostomy tube, the third continuous ridgecreating a fourth region within the third region.
 5. The inner cannulaof claim 4, wherein the fourth region is connectable to a line coupledto a source of irrigant.
 6. An irrigating intraluminal suction innercannula system comprising: a tracheostomy tube having an opening betweenthe inner lumen of the tracheostomy tube and a subglottic extraluminalspace outside the tracheostomy tube, the opening contiguous with thethird region; the inner cannula of claim 1 positioned inside thetracheostomy tube; an irrigant line in communication with the firstregion; a first suction line in communication with the second region; asecond suction line in communication with the third region; and anactuating device coupled between the irrigant line and a source ofirrigant and coupled between the first and second suction lines and avacuum source, said actuating device controllably connecting theirrigant line to the source of irrigant and the first and second suctionlines to the vacuum source.
 7. The cannula system of claim 6, whereinthe tracheostomy tube further comprises indentations on an inner surfacein the same pattern as the first and second continuous ridges such thatthe first and second continuous ridges engage with the indentations whenthe inner cannula is inserted into the tracheostomy tube.
 8. The cannulasystem of claim 6, wherein the actuating device may be coupled betweenonly the first and second suction lines and the inner cannula.
 9. Thecannula system of claim 6, wherein the actuating device may beincorporated within a ventilator.
 10. The cannula system of claim 6,wherein the source of irrigant is positioned at a distance below avertical height of the inner cannula to prevent spontaneous flow. 11.The cannula system of claim 10, further comprising a flow sensor formonitoring excessive or unexpected flow of irrigant or suction.
 12. Thecannula system of claim 11, further comprising valves, flow-limiters,mechanical flow and pressure sensors, or electrical flow and pressuresensors.
 13. The cannula system of claim 12, further comprising an alarmor notification when excessive or unexpected flow of irrigant or suctionis detected.
 14. The cannula system of claim 6, wherein the tracheostomytube and the inner cannula form a single device.
 15. An irrigatingintraluminal suction inner cannula system comprising: a tracheostomytube having, plurality of openings between the inner lumen of thetracheostomy tube and a subglottic extraluminal space outside thetracheostomy tube, a first opening of the plurality of openingscontiguous with the third region and a second opening of the pluralityof openings contiguous with the fourth region; the inner cannula ofclaim 4 positioned inside the tracheostomy tube; a first irrigant linein communication with the first region; a second irrigant line incommunication with the fourth region; a first suction line incommunication with the second region; a second suction line incommunication with the third region; and an actuating device coupledbetween the first and second irrigant lines and a source of irrigant andcoupled between the first and second suction lines and a vacuum source,said actuating device controllably connecting the first and secondirrigant lines to the source of irrigant and the first and secondsuction lines to the vacuum source.
 16. A method of cleansing theirrigating intraluminal suction inner cannula system of claim 6, themethod comprising: attaching the first suction line so that it is incommunication with the second region; attaching the second suction lineso that it is in communication with the third region; attaching theactuating device between the first and second suction lines and a vacuumsource, said actuating device controllably connecting the first andsecond suction lines to the vacuum source; and controlling the actuatingdevice to apply suction to a lumen of the inner cannula through theplurality of holes and the second region, and to apply suction to thesubglottic extraluminal space outside the tracheostomy tube through theopening and the third region.
 17. The method of claim 16, furthercomprising: attaching the irrigant line so that it is in communicationwith the first region; attaching the actuating device between theirrigant line and a source of irrigant, said actuating devicecontrollably connecting the irrigant line to the source of irrigant; andcontrolling the actuating device to provide irrigant to the lumen of theinner cannula through the plurality of holes and the first region.
 18. Amethod of cleansing the irrigating intraluminal suction inner cannulasystem of claim the method comprising: attaching the first suction lineso that it is in communication with the second region; attaching thesecond suction line so that it is in communication with the thirdregion; attaching the actuating device between the first and secondsuction lines and a vacuum source, said actuating device controllablyconnecting the first and second suction lines to the vacuum source; andcontrolling the actuating device to apply suction to a lumen of theinner cannula through the plurality of holes and the second region, andto apply suction to the subglottic extraluminal space outside thetracheostomy tube through at least one opening of the plurality ofopenings and the third region.
 19. The method of claim 18, furthercomprising: attaching the first irrigant line so that it is incommunication with the first region; attaching the second irrigant lineso that it is in communication with the fourth region; attaching theactuating device between the first and second irrigant lines and asource of irrigant, said actuating device controllably connecting thefirst and second irrigant lines to the source of irrigant; andcontrolling the actuating device to provide irrigant to the lumen of theinner cannula through a plurality of holes and the first region, and tothe subglottic extraluminal space outside the tracheostomy tube throughat least one opening of the plurality of openings and the fourth region.20. An inner cannula for use with a fenestrated tracheostomy tube,comprising: a tube having a diameter for insertion in the tracheostomytube, a distal end and a proximal end, said tube further comprising: aplurality of holes between an intraluminal space of the tube and anouter surface of the tube, and a continuous ridge on the outer surfaceof the tube, the continuous ridge having a height that abuts an innerlumen of the tracheostomy tube, wherein the continuous ridge extends atleast along a first length of the tube in a proximal direction, around acircumference of the tube, and along a second length of the tube in thedistal direction, the continuous ridge dividing an airspace surroundingthe outer surface into a plurality of separate regions including atleast a first region and a second region; a raised area having a heightthat abuts an inner lumen of the tracheostomy tube in the region of afenestration of the tracheostomy tube.
 21. The inner cannula of claim20, wherein the raised area comprises a platform that blocks the flow ofair through the fenestration of the tracheostomy tube.
 22. The innercannula of claim 20, wherein the raised area comprises a raised ridgesurrounding an opening in the inner cannula that allows for passage ofair between the intraluminal space of the tube and an extraluminal spaceof the tracheostomy tube.
 23. The inner cannula of claim 20, wherein thefirst region is connectable to a line coupled to a source of irrigant.24. The inner cannula of claim 20, wherein the second region isconnectable to a line coupled to a vacuum source.